RecruitingPhase 3NCT07052669

Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC

Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study


Sponsor

Sun Yat-sen University

Enrollment

311 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two radiation approaches for people with inoperable, locally advanced non-small cell lung cancer (NSCLC). One approach delivers radiation in fewer, larger daily doses (hypofractionated), while the other uses the standard smaller daily doses. Both are combined with chemotherapy, and may be followed by immunotherapy. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with stage III non-small cell lung cancer that cannot be surgically removed - Your tumor does not have EGFR mutations or ALK rearrangements (common genetic changes that affect treatment) - You have not received prior systemic treatment, OR you received induction chemotherapy with or without immunotherapy - Your overall health is reasonably good and your expected survival is at least 12 weeks - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - You have small cell lung cancer or another subtype not classified as NSCLC - Your tumor has EGFR or ALK gene changes - Your general health is too poor to tolerate treatment - You have active autoimmune disease or serious heart/lung conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Radiation Therapy

All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 \~2400 cGy in 5\~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.

RADIATIONConventionally Fractionated Radiation Therapy

Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.

DRUGConcurrent Chemotherapy

Paclitaxel plus platinum-based chemotherapy.

DRUGconcurrent chemotherapy

Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.

DRUGConsolidative immunotherapy

Following the completion of chemoradiotherapy, PD-1/PD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.


Locations(3)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07052669


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